Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Criteria

Inclusion Criteria:

->18 years of age

• Advanced liver disease

• Able to give written, informed consent

• Alcohol as a cause of advanced liver disease

• Continued sustained drinking

• Having previously declined a referral to traditional AUD therapy services or having failed such treatments

Exclusion Criteria:

• Lack of sustained drinking

• Recent or current alcoholic hepatitis

• Alcohol withdrawal symptoms

• Clinically significant use of illicit drugs

• Uncontrolled mood disorders or primary psychotic conditions

• MELD score>17

• Unclear diagnosis of chronic liver disease

• Current hepatic encephalopathy on lactulose and/or rifaximin

• WBC count<1000

• Non-elective hospitalization within last month

• on dialysis

• known untreated, in-situ luminal GI cancers

• chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)

• Dysphagia within 2 weeks

• History of aspiration, gastroparesis, intestinal obstruction

• Ongoing absorbable antibiotic use

• Severe anaphylactic food allergy

• allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)

• Adverse event attributable to prior IMT

• ASA Class IV or V

• Pregnant or nursing patients

• acute illness or fever on the day of planned FMT

• Immunosuppression

• Other conditions which make patients are poor candidate for this study per investigator judgement